Back to resultsStudy of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension
Primary Purpose
Primary Open-angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Brinzolamide 1% added to Travoprost 0.004%
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open-angle Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Patients who are treated with any prostaglandin analogue monotherapy (excluding unoprostone) and who have an intraocular pressure between 19 and 32 mmHg at 08:00 hours.
Exclusion Criteria:
- Under 18 years
Sites / Locations
- Mainz Site
Outcomes
Primary Outcome Measures
Mean diurnal intraocular pressure at month 3
Secondary Outcome Measures
Individual intraocular pressures measured at 08:00, 12:00 and 16:00 at month 3.
Reduction from baseline in mean diurnal intraocular pressure and individual timepoints.
Visual acuity, Slit lamp biomicroscopy and adverse events during 3 months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00372827
Brief Title
Study of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension
Official Title
Efficacy and Safety of Timolol Maleate 0.5% Compared to Brinzolamide 1% When Added to Travoprost 0.004% in Primary Open-angle Glaucoma or Ocular Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to compare the efficacy and safety of Timolol 0.5% solution to Brinzolamide 1% each given twice daily when added to Travoprost 0.004% given each evening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open-angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
245 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1% added to Travoprost 0.004%
Primary Outcome Measure Information:
Title
Mean diurnal intraocular pressure at month 3
Secondary Outcome Measure Information:
Title
Individual intraocular pressures measured at 08:00, 12:00 and 16:00 at month 3.
Title
Reduction from baseline in mean diurnal intraocular pressure and individual timepoints.
Title
Visual acuity, Slit lamp biomicroscopy and adverse events during 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are treated with any prostaglandin analogue monotherapy (excluding unoprostone) and who have an intraocular pressure between 19 and 32 mmHg at 08:00 hours.
Exclusion Criteria:
Under 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Grau
Organizational Affiliation
Study Manager
Official's Role
Study Director
Facility Information:
Facility Name
Mainz Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
17191187
Citation
Hollo G, Chiselita D, Petkova N, Cvenkel B, Liehneova I, Izgi B, Berta A, Szaflik J, Turacli E, Stewart WC. The efficacy and safety of timolol maleate versus brinzolamide each given twice daily added to travoprost in patients with ocular hypertension or primary open-angle glaucoma. Eur J Ophthalmol. 2006 Nov-Dec;16(6):816-23. doi: 10.1177/112067210601600606.
Results Reference
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Learn more about this trial
Study of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension
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